The pharmaceutical industry has sought intervention of prime minister office (PMO) to resolve the long pending issue related to replacement of gelatin capsule with cellulose based capsule which is of plant origin.
Pharmaceutical industry bodies viz. Indian Drug Manufacturers' Association (IDMA), PHD Chamber of Commerce and Industry (PHDCCI) called on principal secretary to PMO Nripendra Mishra recently in New Delhi and apprised him of disadvantages and infeasibility of changing over from gelatin capsules to cellulose capsules. They appealed to Mishra to intervene and let pharmaceuticals and medicines be developed totally on scientific basis and not on sentiments.
The proposal to replace gelatin capsules with cellulose capsules originates from the concept of vegetarianism vs non-vegetarianism. Neither industry nor people will benefit from this change over, opined PHDCC.
PHDCC having members contributing to 95% of gelatine manufactured in India in its representation to Mishra stated that gelatin capsules have been in use more than a century across the globe. So far no technical evidence of gelatin capsules suggested that its harmful for human consumption. Across the globe over 95% of capsule formulations are gelatin capsules and even among the rest 5%, hydroxypropylmethyl cellulose (HPMC) is primarily used for nutraceutical formulations. In India only around 2% capsules are HPMC based and almost all of them are nutraceuticals.
No cellulose capsules are used for products such as antibiotics, oncology, anti-infectious, painkiller and other medicinal categories. Nor have any tests been carried out by the DCGI in India whether such medicinal products would maintain their stability, bio-availability, bio-equivalence and other properties if filled in cellulose capsules, it said.
The Pharmacopoeias of the US, European Union, Japan, Australia, South Africa and India etc have stated that gelatin capsules are safe. Drugs Technical Advisory Board on May 13, 2016 ruled that unlike food, drugs are not taken by choice but re prescribed by the doctors to save lives and making them as vegetarian or non vegetarian origin is not desirable.
The PHDCCI has also submitted a representation to the Expert Committee set up by Ministry of Health and Family under chairmanship of Prof CK Kokate to address all the technical issues pertaining to replacement of gelatin capsules with cellulose based capsules for encapsulation of drugs.
IDMA secretary general Dara Patel in the representation to Mishra stated that gelatin capsules have been in use for over 100 years. It has been found to be very safe for human consumption and accordingly it has been accepted by regulators all over the world. Thousands of crores have been spent on establishing the quality, viability and economics of gelatin capsules. There have been no adverse reports of gelatin capsules.
“We are totally self-sufficient with the raw materials for gelatin capsules. We will be totally dependent on imports of raw materials for cellulose capsules. The safety and efficacy of cellulose capsules cannot be guaranteed. Members are concerned that even after approvals, few long term studies may show adverse reports and they may not want to take the responsibility for that. Today we manufacture 120 billion gelatin capsules compared to only 2 billion cellulose capsules. Cellulose capsules are 2-3 times expensive compared to gelatin capsules. This would increase the cost of drugs to the patients. Huge investment in plant and machinery would be required to adopt cellulose capsules,” Patel said.
If gelatin capsules would be substituted with cellulose capsules, there would be a panic situation in the industry apart from uncertainty and anxiety. Hence IDMA appealed to the government to continue to allow use of gelatin capsules to ensure availability of safe, efficacious and affordable drugs to the patients.
Mishra considering views of the industry representatives finally agreed that both types of capsules should co-exist.
It may be noted that the Directorate General of Health Services vide notice dated June 02, 2017, had sought views of various stakeholders to address all the technical issues pertaining to replacement of gelatin capsules with cellulose based capsules for encapsulation of drugs.